Legal Counsel Corporate And Regulatory Affairs - Transactions Atlantic Health System IncLegal Counsel Corporate And Regulatory Affairs - TransactionsMorristown, NJServe as a key legal resource on healthcare regulatory matters, including fraud and abuse laws (Stark Law and Anti-Kickback Statute), HIPAA, EMTALA, Medicare and Medicaid requirements, licensure, reimbursement, corporate governance, tax-exempt organization issues, pay-to-play requirements, and other federal and state healthcare regulations. Build strong working relationships with leaders in Finance, Strategy, Compliance, Privacy, Risk Management, Internal Audit, Human Resources, Supply Chain, Information Technology, Clinical Operations, and other functional areas to facilitate sound business decisions and effective risk management.
Sr. Medical Science Liaison - NorthEast Rigel Pharmaceuticals IncSr. Medical Science Liaison - NorthEastNY$183,000–$220,000 / yearMSL) serves as field-based medical resource for compliant scientific exchange on Rigel pipeline, areas of research, approved products, and associated disease states with healthcare providers, patient advocacy groups, payors, other industry partners, as well as internal colleagues at Rigel. MSL will be on supporting Rigels approved oncology product for metastatic breast cancer but may require support of other approved products in hematology/oncology, as well as supporting any development or launch-related activities for Rigels pipeline, or in-licensed molecules.
Director RA Global Regulatory Strategy AbbVie IncDirector RA Global Regulatory StrategyFlorham Park, NJThe Director Regulatory Affairs Global Regulatory Lead (GRL II), Global Regulatory Strategy, is responsible for developing and implementing global strategies to secure and maintain market approval for product(s) in the assigned therapeutic area. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position.
Manager, Regulatory Affairs Strategy - Oncology Regeneron PharmaceuticalsManager, Regulatory Affairs Strategy - OncologyTarrytown, NY$128,600–$210,000 / yearDiscover your role: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
Director, Commercial Data & Digital Solutions Teva Pharmaceutical Industries LtdDirector, Commercial Data & Digital SolutionsParsippany, NJ$161,000–$202,000 / yearThis role partners closely with Marketing, Sales, Commercial Operations, Patient Services, Medical Affairs, Market Access, and external partners to create scalable, compliant, and insight driven solutions that accelerate brand performance and customer engagement. The IT Director, Commercial Data & Digital Solutions will lead the strategy, delivery, and continuous evolution of data, analytics, and digital capabilities that power Commercial excellence across innovative pharmaceutical brands.
Regulatory Affairs/Quality Affairs Specialist ElliquenceRegulatory Affairs/Quality Affairs SpecialistBALDWIN, NYFull timeCreate documentation in response to customer regulatory requests which includes regulatory letters, authorization letters, certifications, attestations, technical packages, etc. for tenders and for pre-market clearance. This role collaborates cross-functionally across the organization to prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.
Scientific - Global Regulatory CMC Manager TechDigital CorporationScientific - Global Regulatory CMC ManagerSummit, NJ2. Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision. Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions.
NewClinical Regulatory Specialist Iterative Scopes IncClinical Regulatory SpecialistNew York, NYYou will collaborate with site teams, internal stakeholders, sponsors, CROs, IRBs, and other external partners to ensure regulatory requirements are completed accurately, efficiently, and in accordance with applicable guidelines and study requirements. Working under the direction of a Clinical Regulatory Manager Director, you will partner closely with clinical research sites to manage regulatory activities throughout the study lifecycle-from study start-up and activation through ongoing maintenance and closeout.
Head of Medical Information Bristol-Myers Squibb CoHead of Medical InformationNY$210,572–$255,164 / yearThe team member will serve as a subject matter expert for internal and external audiences, act as the primary liaison to Bristol Myers Squibb's (BMS) Medical Information organization to ensure alignment of processes, systems, and shared services, and contribute to cross-functional Medical Affairs initiatives supporting RayzeBio's radiopharmaceutical portfolio. Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
Director, Regulatory Affairs Strategy - Genetics Medicine Regeneron PharmaceuticalsDirector, Regulatory Affairs Strategy - Genetics MedicineTarrytown, NY$205,000–$341,600 / yearThe Director will develop and maintain regulatory strategy at the study, indication, and program level, lead interactions with global health authorities, and serve as a key cross-functional partner and subject matter expert. Working with cross-functional project teams to resolve complex regulatory issues, utilizing deep expertise in global regulations and guidances to strategically plan and communicate requirements.
Manager, Regulatory Affairs Strategy - Immunology & Inflammation Regeneron Pharmaceuticals IncManager, Regulatory Affairs Strategy - Immunology & InflammationTARRYTOWN, NY$128,600–$210,000 / yearA typical day might include the following: Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator's Brochure. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
NewDirector, Medical Information Compass PathwaysDirector, Medical InformationNew York, NYRemote$210,000–$255,000 / yearWorking cross-functionally across Medical Affairs, Scientific Communications, Medical Education, Evidence Generation, Pharmacovigilance, Regulatory, Legal, Compliance, and Commercial, this individual will help ensure Medical Information strategies are aligned with broader organizational objectives and evolving scientific priorities. The Director will also be responsible for identifying opportunities to optimize Medical Information processes, leveraging insights from medical inquiries to inform Medical Affairs strategy, and driving innovation through best-in-class technologies, analytics, and service delivery models.
Senior Counsel Global Commercial Legal - Oncology AbbVie IncSenior Counsel Global Commercial Legal - OncologyFlorham Park, NJMinimum of 5+ years of relevant experience practicing in-house at a pharmaceutical company, practicing as a member of a nationally recognized law firm in a life sciences or healthcare practice, or practicing as an attorney for a government agency, or any combination of the above. Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
Sr. Quality Assurance Manager (Pharma) Prestige Consumer Healthcare IncSr. Quality Assurance Manager (Pharma)Tarrytown, NY$150,000–$175,000 / yearSuccess in this position requires strong cross-functional collaboration with internal stakeholders, including Regulatory Affairs, Medical Affairs, Strategic Sourcing, New Product Development, Package Development, Supply Planning, and Logistics, as well as the ability to influence quality outcomes across a network of third-party manufacturing partners. Evaluate the effectiveness of contract manufacturing partners quality systems by leading effective audits for cGMP compliance, issuing audit reports, managing contract manufacturing partners response adequacy and timeliness; determining system improvements.
Medical Science Liaison - North Central U.S. Veloxis Pharmaceuticals, IncMedical Science Liaison - North Central U.S.New York, New York$170,000–$207,000Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships and represent the Company's interests, including those in national and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research. The Medical Science Liaison contributes to the Company's success by utilizing scientific exchange and interpersonal skills to develop relationships with healthcare practitioners (HCPs), including key opinion leaders, seeking to optimize patient outcome through proper understanding of the disease state, appropriate patient identification and appropriate utilization of the Company's product.
Medical Science Liaison - North Central U.S. Bionique Testing Laboratories LLCMedical Science Liaison - North Central U.S.New York, New York$170,000–$207,000Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships and represent the Company's interests, including those in national and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research. The Medical Science Liaison contributes to the Company's success by utilizing scientific exchange and interpersonal skills to develop relationships with healthcare practitioners (HCPs), including key opinion leaders, seeking to optimize patient outcome through proper understanding of the disease state, appropriate patient identification and appropriate utilization of the Company's product.
Medical Science Liaison - Transplant / Infectious Diseaes (Mid-Atlantic region) Veloxis Pharmaceuticals, IncMedical Science Liaison - Transplant / Infectious Diseaes (Mid-Atlantic region)New York, New York$170,000–$207,000Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships and represent the Company's interests, including those in national and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research. The Medical Science Liaison contributes to the Company's success by utilizing scientific exchange and interpersonal skills to develop relationships with healthcare practitioners (HCPs), including key opinion leaders, seeking to optimize patient outcome through proper understanding of the disease state, appropriate patient identification and appropriate utilization of the Company's product.
Associate Director or Director, Medical Science Liaison, Oncology - Northeast and Mid-Atlantic region / Field-based Eisai IncAssociate Director or Director, Medical Science Liaison, Oncology - Northeast and Mid-Atlantic region / Field-basedNYRemote$206,600–$271,215 / yearThe Associate Director / Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL).
Associate Director or Director, Medical Science Liaison, Oncology - Northeast and Mid-Atlantic region / Field-based EisaiAssociate Director or Director, Medical Science Liaison, Oncology - Northeast and Mid-Atlantic region / Field-basedNutley, NJRemote$206,600–$271,215 / yearThe Associate Director / Director, MSLs is responsible for the leadership, direction and management of MSLs in the region and works collaboratively with the Medical Affairs Senior management with strategic and tactical planning, working collaboratively with Medical Affairs and Clinical Development teams for support of clinical studies across the product portfolio. Skills:Communication & Cross-functional Influence, Critical Thinking & Agility, Healthcare Environment Dynamics, KOL/ HCP Engagement, Medical Data and Insights, People Development, Resource Planning & Management, Territory Management (MSL).
Medical Science Liaison - North Central U.S. Asahi Kasei Semiconductor, Inc.Medical Science Liaison - North Central U.S.New York, New York$170,000–$207,000Identifies and conducts outreach to key HCPs within the assigned territory to build and strengthen relationships and represent the Company's interests, including those in national and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research. The Medical Science Liaison contributes to the Company's success by utilizing scientific exchange and interpersonal skills to develop relationships with healthcare practitioners (HCPs), including key opinion leaders, seeking to optimize patient outcome through proper understanding of the disease state, appropriate patient identification and appropriate utilization of the Company's product.